HAND SANITIZER- alcohol gel 
SOFi Paper Products LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hand Sanitizer

Drug Facts

Active Ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Use

Warnings

Flammable, Keep away from fire or flame.

For external use only

When using this product

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or rash appears and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other Information

Inactive Ingredients:

Water, Triethanolamine, Carbopol, Tween 20, Glycerin, Aloe

Package Labeling:78227-000-01

Label

Package Labeling:78227-000-02

Label2

Package Labeling:78227-000-03

Label3

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78227-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE (UNII: V5VD430YW9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78227-000-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2020
2NDC:78227-000-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2020
3NDC:78227-000-033785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/25/2020
Labeler - SOFi Paper Products LLC (117491636)

Revised: 6/2020
Document Id: a7d08f4a-f735-3500-e053-2995a90a856c
Set id: 99c30aa4-4880-4ef7-9602-f84d04244d93
Version: 2
Effective Time: 20200611
 
SOFi Paper Products LLC